Status:
COMPLETED
Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital Research Institute
Conditions:
Sars-CoV2
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
\*\*\*At this time, we are only enrolling at Houston Methodist Hospital (HMH)/Baylor College of Medicine (BCM) and are not shipping cells outside of BCM/HMH.\*\*\* This is a study for patients who ha...
Detailed Description
Earlier, a healthy donor provided blood cells to generate MSCs. These cells were grown and frozen for later use. Before being treated, the patient will receive a series of standard medical tests: The...
Eligibility Criteria
Inclusion
- 18 years or older
- Confirmed SARS-CoV2 infection real-time reverse transcription polymerase chain reaction (RT-PCR) assay
- Moderate OR severe ARDS, based on the degree of impairment of oxygenation as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2):
- Moderate ARDS: PaO2/FiO2 100-200 mmHg OR
- Severe ARDS: PaO2/FiO2 ≤100 mmHg
- If on invasive or noninvasive (BiPAP) mechanical ventilator, PEEP ≥5 cm H2O
- Bilateral opacities present on chest radiograph or computed tomographic (CT) scan, that are not fully explained by pleural effusions, lung collapse, or lung nodules.
Exclusion
- Currently receiving extracorporeal membrane oxygenation (ECMO)
- Severe chronic respiratory disease requiring use of home oxygen
- Pregnant or lactating
- Known hypersensitivity to dimethyl sulfoxide (DMSO)
- Unstable hemodynamics as deemed by the treating physician/investigator including but not limited to unstable, ventricular tachycardia or new cardiac arrythmia requiring cardioversion.
- Uncontrolled bacterial or fungal co-infection
- Any end-stage organ disease or condition, which in the opinion of the Investigator, makes the patient an unsuitable candidate for treatment
- Inability to obtain informed consent (from patient or legally appropriate proxy)
- Presence of any contraindication to receiving prophylactic low dose unfractionated or low molecular weight heparin.
- Respiratory failure not fully explained by cardiac failure or fluid overload.
Key Trial Info
Start Date :
February 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04345601
Start Date
February 12 2021
End Date
January 10 2023
Last Update
October 9 2024
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030